A new phase II trial of mogamulizumab demonstrated that this agent could be a new option for patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma.
This patient population, in particular those with PTCL, have options in terms of chemotherapy regimens, but none are terribly successful, and patients tend to experience poor outcomes.
Mogamulizumab is a monoclonal antibody targeting CC chemokine receptor 4. CCR4 is expressed on tumor cells in 30-65 percent of PTCL patients, and CCR4-positive patients have shorter survival than those not expressing the protein.
The agent is currently only approved in Japan.
This phase II trial was led by Michinori Ogura, M.D., Ph.D., of Nagoya Daini Red Cross Hospital in Nagoya, Japan. It involved 37 patients with relapsed CCR4-positive PTCL or CTCL.
The median age of patients was 64 years, with 62 percent being male. They had a median of two previous systemic regimens. Nine underwent radiotherapy before entering the study. Twenty-four patients had an ECOG status of 0, twelve were ECOG 1, and one patient was ECOG 2.
Patients received IV mogamulizumab 1 mg/kg once per week for eight weeks.
Thirteen of 37 patients had an objective response to mogamulizumab. Five patients achieved a complete response. The median progression-free survival was three months, and median overall survival for the full cohort was not reached; specifically for those with PTCL, the median overall survival was 14.2 months. The overall response rate was 34 percent in patients with PTCL, and 38 percent in those with CTCL. The median progression-free survival for the 13 responders was 5.5 months, and 8.2 months for the PTCL responders.
Researchers concluded:
This phase II study revealed that mogamulizumab had promising efficacy and tolerability in patients with relapsed CCR4-positive PTCL and CTCL. Given its novel mechanism of action and favorable toxicity profile compared with multi-agent cytotoxic chemotherapy, we might expect the use of mogamulizumab in combination with other agents. Further pre-clinical and clinical studies of combination therapy will be needed.
These findings were published online ahead of print in the Journal of Clinical Oncology.
Source: JCO